October 22, 2020

The Niche

Knoepfler lab stem cell blog

‘I’d need a drink’: WaPo deep dive on clinic firm Lung Health Institute

Washington Post reporters William Wan and Laurie McGinley have a new piece on the unproven regenerative clinic firm the Lung Health Institute. This article has a number of surprises and new insights.

“Former patients of the Tampa-based Lung Health Institute said they were encouraged to take out bank loans or borrow money from family members. Some withdrew from their retirement accounts and took up church offerings. Others borrowed against their homes…Since 2013, the company has conducted a multimillion-dollar campaign to lure patients with targeted online ads, hyped claims and high-pressure seminars, according to internal documents and former staff…In interviews, former employees responsible for fielding patients’ calls said they were given monthly sales quotas. Former company doctors and nurses described working as “closers,” using their medical credentials to persuade wavering patients to put money down.”

This sounds like a familiar hard sell of the clinic arena to me. Lots of marketing strategy, but what about hard data from controlled studies?

Arnold Caplan
Professor Arnold Caplan.

The biggest surprise of the WaPo story and disappointing news to me is that stem cell scientist and Professor Arnold Caplan is acting as a hired expert for the Lung Health Institute:

“A stem cell researcher, Arnold Caplan — hired by the Lung Health Institute to testify in court as its expert — said he found the data convincing.

“The truth is, I don’t exactly know how [the treatments] work,” said Caplan, a biologist at Case Western Reserve University. But after seeing the phone surveys conducted by the company, he said, “The important point for me is, there are clearly statistically relevant and positive outcomes from these treatments.”

But three leading pulmonologists with no connection to the company or to any legal action said they found the data unconvincing and flawed, given its lack of comparative groups and placebo controls and other methodological problems.

“It’s borderline propaganda to suggest this information is evidence of efficacy,” said Cosgrove, a pulmonologist at National Jewish Health in Denver, which runs one of the world’s largest interstitial lung disease programs.”

Phone surveys? No control subjects?

That doesn’t sound like convincing data to me by a long shot.

Furthermore, as a stem cell biologist, I can’t think of any reasonable way that PRP administered IV (and hence diluted in the entire bloodstream) could meaningfully help pulmonary diseases. Am I missing something here? I can’t imagine they infuse the PRP into the respiratory system itself and even if they could, why would it help?

The WaPo also delved even more into the company’s marketing and included this quote from the COO Ann Sells Miller (pictured from the company website):

H-CYTE Ann Sells Miller
H-CYTE COO Ann Sells Miller, from the company website.

“In two lengthy interviews, the company’s chief operating officer, Ann Sells Miller, defended the company, saying its treatments have helped many patients who have no other options. Miller and other executives dismissed complaints about their marketing strategies and treatments, saying that their critics are often people who don’t understand their stem cell procedures or lawyers looking to make money by filing lawsuits against them.

According to a 2013 marketing script, if patients asked whether the treatments were approved by the Food and Drug Administration, coordinators were taught to respond: Although “the treatments are not FDA approved . . . all of the drugs and equipment we use are FDA-approved.”

So us critics just are ignorant or are attorneys?

Another notable part of this story is it has insights from sales reps that provide a unique window into the dynamic that is rather startling:

“Several patient coordinators said they were troubled by these calls. “Some people wouldn’t have that much money, and you’re doing everything you can to convince them to use it on something you’re not sure even works,” said a woman who worked at the Lung Health Institute for two years and left for another company after she said she became uncomfortable with the job. “People would call afterward and say, ‘I trusted you, but I don’t feel any better.’ Some would call just to yell: ‘I spent all this money, and you guys said this and that. You sold me fake medicine.’ Often I’d need a drink by the end of the day.”

Yikes.

Interestingly, although Google only recently instituted a ban on stem cell clinic ads, it apparently acted earlier on the Lung Institute, although the reason why isn’t clear in the WaPo piece:

“In the summer of 2017, Google suddenly stopped permitting the Lung Health Institute to buy search engine ads, a crucial source of sales leads, according to five former employees.

Lung Health Institute officials denied they did anything wrong and said that “Google began to update its internal policy and rules for advertising related to regenerative medicine.” Company officials said, “[We] hold ourselves to the highest standards and will continue to evolve to stay within guidelines.”

The result was a sharp drop in sales leads. “They told us to start calling back every one of our old leads, to hand out discounts and offer booster treatments to past patients,” one former coordinator said. “We didn’t know if we were going to survive.”

Yet, the company survived and now seems to be raising big bucks and claiming important affiliations:

“Meanwhile, Lung Health Institute executives have made plans to expand. Late last year, the Lung Health Institute was acquired by Medovex, a medical technology products company run by former Laser Spine executive William “Bill” Horne. In April, the company raised $7.2 million in new capital, and in recent weeks it raised another $6 million. Horne has said he plans to open more Lung Health Institute clinics.

In July, Medovex announced it was changing its name to “H-CYTE” and had entered into a business partnership with a start-up called Rion LLC — run by two researchers from the prestigious Mayo Clinic — to develop a new “proprietary cellular platform” to treat COPD.

In news releases, the company said the two researchers — Atta Behfar and Andre Terzic, who research regenerative medicine at Mayo — had joined its board of directors.”

Perhaps as a result of the suit and other issues, now another media report says the firm is having to layoff employees so seems surprising given all the money mentioned above. Note that Behfar and Terzic both of the Mayo, are not currently on the board according to the WaPo, but at the moment I checked they are still listed on the company website as being on the board.
Overall, we’ll have to keep an eye on the Lung Health Institute and H-CYTE, and in particular that lawsuit. I expect some big developments in the coming year.